MAUDE Adverse Event Report: PROVIDENCE MEDICAL TECHNOLOGY, INC. DTRAX CERVICAL CAGE-B; CERVICAL INTERVERTEBRAL FUSION DEVICE

Model Number	PD-31-200
Medical Device Problem Codes	Malposition of Device (2616); Patient-Device Incompatibility (2682); Positioning Problem (3009)
Health Effect - Clinical Codes	Pain (1994); Inadequate Pain Relief (2388)
Date of Event	03/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Note: the event in this mdr is exactly the same as mdr # 3009394448-2016-00002 except for the product lot information.The event is not a death situation.There was no life-threatening injury or any serious injury that resulted in permanent impairment of body function or structure reported.However, there was illness in the sense that the patient experienced unrelieved pain after the original procedure due to possible nerve impingement which may result when cages were not located in the intended joint space.The pain led to the re-intervention.The patient's "large facet" joint space as noticed by the surgeon may have contributed to cage movement leading to "subsidence".Although there was no device defect or malfunction reported in this case, the "subsided" implants led to a revision and therefore failed to perform as intended.For this reason, this event was reported.Not device defect related.
Event or Problem Description
A patient previously implanted with cervical cages from c4-t1 went through a revision on (b)(6) 2016 due to right arm and ulnar pain.The surgeon discovered through post-op x-ray examination that three cages had subsided "laterally" and came out easily when the surgeon used a kocher instrument to remove them during revision.The surgeon who performed the revision had noted that this patient has "large facets".All cages from c4-t1 were removed and replaced with hook and rod fusion.There was no device malfunction reported.The patient did not report any new or worsening symptoms after revision.

• Brand Name: DTRAX CERVICAL CAGE-B
• Common Device Name: CERVICAL INTERVERTEBRAL FUSION DEVICE
• Manufacturer (Section D): PROVIDENCE MEDICAL TECHNOLOGY, INC.; 1331 n. california blvd.; suite 320; walnut creek CA 94596
• MDR Report Key: 6090143
• Report Number: 3009394448-2016-00003
• Device Sequence Number: 13876668
• Product Code: ODP
• UDI-Device Identifier: 00852776006003
• UDI-Public: 00852776006003
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K122801
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 09/10/2017
• Device Model Number: PD-31-200
• Device Catalogue Number: PD-31-200
• Device Lot Number: 1116223
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2016
• Initial Report FDA Received Date: 11/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Weight: 75